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SHANGHAI ZJ BIO-TECH CO., LTD.

China·CN-MF-000017861

Last updated September 17, 2026

Information

Country
China
Address
2168 Chenhang Road, Building #9-301-11, 2168 Chenhang Road Minhang District, Shanghai , China
LinkedIn
—
Facebook
—
Phone
+86-21-34680598
PRRC Contact
Yiyun Wang
EUDAMED SRN
CN-MF-000017861
FDA FEI Number
3007143373
DUNS Number
—

Catalogue (316)

Page 3 of 7
DeviceModel / ReferenceRegistriesClassStatus
N2 Gene of Influenza Virus A Real Time RT-PCR Kit RR-0321-02
EUDAMED
IVD GeneralActive
Rotavirus (Group C) Real Time RT-PCR Kit DR-0185-02
EUDAMED
IVD GeneralActive
New influenza A virus Real Time RT-PCR Panel RR-0138-02
EUDAMED
IVD GeneralActive
Mycoplasma Genitalium (MG) Real Time PCR Kit SD-0278-02
EUDAMED
IVD GeneralActive
Salmonella & Shigella Real Time PCR Kit DD-0035-02
EUDAMED
IVD GeneralActive
Novel Coronavirus (SARS-CoV-2) Real-Time Multiplex RT-PCR Kit (RR-0485-02) RR-0485-02
EUDAMED
IVD GeneralActive
HEV Real Time RT-PCR Kit HR-0011-02
EUDAMED
IVD GeneralActive
Rift Valley Fever Virus (RVFV) Real Time RT-PCR Kit AR-0116-02
EUDAMED
IVD GeneralActive
Leukemia CBFB-MYH11 A Fusion Gene Real Time RT-PCR Kit TR-0284-04
EUDAMED
IVD GeneralActive
Dengue Virus IV Real Time RT-PCR Kit ER-0064-04
EUDAMED
IVD GeneralActive
Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 2 Genes) RR-0508-02-48A
EUDAMED
IVD GeneralActive
Avian Influenza Virus Real Time RT-PCR Kit RR-0047-02
EUDAMED
IVD GeneralActive
Yersinia Enterocolitica Real Time PCR Kit DD-0127-02
EUDAMED
IVD GeneralActive
Group B Streptococcus (GBS) Real Time PCR Kit RD-0237-02
EUDAMED
IVD GeneralActive
Rotavirus Real Time RT-PCR Kit DR-0044-02
EUDAMED
IVD GeneralActive
Human Infections with Avian Influenza A Virus (H7N9) RNA Real Time RT-PCR Kit RR-0309-02
EUDAMED
IVD GeneralActive
Human Parainfluenza Virus Type 2 Real Time RT-PCR Kit RR-0157-02
EUDAMED
IVD GeneralActive
Automated Workstation for Nucleic Acid Extraction and PCR Test ZJYY-D-20215E
EUDAMED
Class AActive
High-risk Human Papillomavirus(HPV)Genotyping Real time PCR kit TD-0324-04-24
EUDAMED
IVD GeneralActive
Mycoplasma Hominis (MH) Real Time PCR Kit SD-0279-02
EUDAMED
IVD GeneralActive
Listeria Monocytogenes Real Time PCR Kit DD-0128-02
EUDAMED
IVD GeneralActive
Dengue Virus General-type Real Time RT-PCR Kit ER-0101-02
EUDAMED
IVD GeneralActive
Liferiver SARS-CoV-2 L452R & E484K/Q Mutations Detection Kit RR-0498-02-25
EUDAMED
IVD GeneralActive
Liferiver® Preservation Medium PR-0031-100
EUDAMED
Class AActive
Coxsackie Virus A16 Real Time RT-PCR Kit QR-0207-02
EUDAMED
IVD GeneralActive
MTHFR C677T Mutation Real Time PCR Kit GD-0135-02
EUDAMED
IVD GeneralActive
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Detection Kit (Colloidal Gold) CG-0002-20
EUDAMED
IVD GeneralActive
Viral Transport Medium PR-0028-100
EUDAMED
Class AActive
Leukemia E2A-PBX1 Fusion Gene Real Time RT-PCR Kit TR-0283-02
EUDAMED
IVD GeneralActive
6 RP Panel I RR-0477-02
EUDAMED
IVD GeneralActive
Specimen Distribution System(AutraMate) ZJYY-D-20219E
EUDAMED
Class AActive
Hemophilus Influenza B Real Time PCR Kit RD-0121-02
EUDAMED
IVD GeneralActive
Salmonella Paratyphi B Real Time PCR Kit DD-0240-02
EUDAMED
IVD GeneralActive
Blood Genomic DNA Isolation Kit (Preloaded for Auto-Extraction) ME-0042
EUDAMED
Class AActive
Streptococcus Pyogenes Real Time PCR Kit RD-0059-02 
EUDAMED
IVD GeneralActive
Malaria Parasite Real Time PCR Kit ED-0066-02
EUDAMED
IVD GeneralActive
Plasmodium Malariae Real Time PCR Kit ED-0216-02
EUDAMED
IVD GeneralActive
IFVA & IFVB & H5/H7N9 Test RR-0226-02
EUDAMED
IVD GeneralActive
10 Viral Diarrhea Pathogens Multiplex Real Time PCR Kit D-0008-02P-12
EUDAMED
IVD GeneralActive
Leukemia PML-RARa Fusion Gene Typing Real Time RT-PCR Kit TR-0280-02
EUDAMED
IVD GeneralActive
Dengue Fever Virus Genotyping Ⅰ/Ⅱ/Ⅲ/Ⅳ Real Time RT-PCR Kit ER-0414-02
EUDAMED
IVD GeneralActive
High-risk Human Papillomavirus(HPV)Genotyping Real time PCR kit(PCR-Fluorescence) TD-0324-02-24
EUDAMED
IVD GeneralActive
Toxic Gene of Vibrio Parahaemolyticus Real Time PCR Kit DD-0155-02
EUDAMED
IVD GeneralActive
Human Rhinovirus (HRV) Real Time RT-PCR Kit RR-0264-02
EUDAMED
IVD GeneralActive
Coxsackie Virus A24 Real Time RT-PCR Kit QR-0081-02
EUDAMED
IVD GeneralActive
Respiratory Syncytial Virus(RSV) Real Time RT-PCR Kit RR-0098-02
EUDAMED
IVD GeneralActive
Human Metapneumovirus (hMPV) Real Time RT-PCR kit RR-0162-02
EUDAMED
IVD GeneralActive
Liferiver ® Auto AT96S A Extraction Kit ME-0046-48
EUDAMED
Class AActive
Crimean-Congo Hemorrhagic Fever Virus(CCHFV) Real Time RT-PCR Kit ER-0133-02
EUDAMED
IVD GeneralActive
HarmoniaHPV Test TD-0552-02-50
EUDAMED
IVD GeneralActive

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